John F.

Brenner
Melissa A. Chuderewicz
PEPPER HAMILTON LLP
Suite 400
301 Carnegie Center Princeton, NJ 08543-5276
(609) 452-0808 - Phone
(609) 452-1147 - Facsimile
Attorneys for Plaintiff
Otsuka Pharmaceutical Co., Ltd.

UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY


OTSUKA PHARMACEUTICAL CO., LTD.

Plaintiff,

v.

ALEMBIC PHARMACEUTICALS
LIMITED, ALEMBIC LIMITED, ALEMBIC
GLOBAL HOLDING SA and ALEMBIC
PHARMACEUTICALS INC.,

Defendants.
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Civil Action No.:

COMPLAINT FOR PATENT INFRINGEMENT
Plaintiff Otsuka Pharmaceutical Co., Ltd. (Otsuka), by way of Complaint against
Defendants Alembic Pharmaceuticals Limited (Alembic Pharmaceuticals Ltd.), Alembic
Limited, Alembic Global Holding SA and Alembic Pharmaceuticals Inc. (collectively,
Alembic), alleges as follows:
THE PARTIES
1. Otsuka is a corporation organized and existing under the laws of Japan with its
corporate headquarters at 2-9 Kanda Tsukasa-machi, Chiyoda-ku, Tokyo, 101-8535, Japan.

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Otsuka is engaged in the research, development, manufacture and sale of pharmaceutical
products.
2. Upon information and belief, Alembic Pharmaceuticals Ltd. is a corporation
organized and existing under the laws of India, having its principal place of business at Alembic
Road, Vadodara 390003, Gujarat, India.
3. Upon information and belief, Alembic Limited is a corporation organized and
existing under the laws of India, having its principal place of business at Alembic Road,
Vadodara 390003, Gujarat, India. Upon information and belief, Alembic Pharmaceuticals Ltd. is
a wholly-owned subsidiary of Alembic Limited.
4. Upon information and belief, Alembic Global Holding SA is a corporation
organized and existing under the laws of Switzerland, having its principal place of business at
40, Rue Fritz-Courvoisier, 2300 La Chaux-de-Fonds, Switzerland. Upon information and belief,
Alembic Global Holding SA is a wholly-owned subsidiary of Alembic Pharmaceuticals Ltd.
5. Upon information and belief, Alembic Pharmaceuticals Inc. is a corporation
organized and existing under the laws of Delaware, having its principal place of business at 116
Village Blvd., Suite 200, Princeton, New Jersey 08650. Upon information and belief, Alembic
Pharmaceuticals Inc. is a wholly-owned subsidiary of Alembic Global Holding SA.
NATURE OF THE ACTION
6. This is an action for infringement of U.S. Patent No. 8,017,615 (the 615
patent), U.S. Patent No. 8,580,796 (the 796 patent), U.S. Patent No. 8,642,760 (the 760
patent) and U.S. Patent No. 8,518,421 (the 421 patent), arising under the United States patent
laws, Title 35, United States Code, 100 et seq., including 35 U.S.C. 271 and 281. This
action relates to Alembic Pharmaceuticals Ltd.s filing of Abbreviated New Drug Applications

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(ANDAs) under Section 505(j) of the Federal Food, Drug and Cosmetic Act (the Act), 21
U.S.C. 355(j), seeking U.S. Food and Drug Administration (FDA) approval to manufacture,
use, sale, offer to sell and import generic pharmaceutical products (Alembic Pharmaceuticals
Ltd.s generic products) prior to the expirations of the asserted patents.
JURISDICTION AND VENUE
7. This Court has subject matter jurisdiction under 28 U.S.C. 1331 and 1338(a).
8. Upon information and belief, this Court has jurisdiction over Alembic
Pharmaceuticals Ltd. Alembic Pharmaceuticals Ltd. is in the business of manufacturing,
marketing, importing and selling pharmaceutical drug products, including generic drug products.
Upon information and belief, Alembic Pharmaceuticals Ltd., directly or through its subsidiaries
Alembic Global Holding SA and Alembic Pharmaceuticals Inc., manufactures, markets, imports
and sells generic drugs throughout the United States and in this judicial district. Upon
information and belief, Alembic Pharmaceuticals Ltd. purposefully has conducted and continues
to conduct business, directly or through its subsidiaries Alembic Global Holding SA and
Alembic Pharmaceuticals Inc., in this judicial district, and this judicial district is a likely
destination of Alembic Pharmaceuticals Ltd.s generic products.
9. Upon information and belief, this Court has jurisdiction over Alembic Limited.
Upon information and belief, Alembic Limited, directly or through its subsidiaries Alembic
Pharmaceuticals Ltd., Alembic Global Holding SA and Alembic Pharmaceuticals Inc.,
manufactures, markets, imports and sells generic drugs throughout the United States and in this
judicial district.
10. Upon information and belief, this Court has jurisdiction over Alembic Global
Holding SA. Upon information and belief, Alembic Global Holding SA, directly or through its

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subsidiary Alembic Pharmaceuticals Inc., manufactures, markets, imports and sells generic drugs
throughout the United States and in this judicial district. Upon information and belief, Alembics
website, http://alembicglobal.ch/index.html, states that Alembic Global Holding SA is the
headquarter for all the overseas business in countries like USA, Europe, UAE, Australia and
other developed markets.
11. Upon information and belief, this Court has jurisdiction over Alembic
Pharmaceuticals Inc. Upon information and belief, Alembic Pharmaceuticals Inc. has its
principal place of business in New Jersey. Upon information and belief, Alembic
Pharmaceuticals Inc., directly or indirectly, manufactures, markets, imports and sells generic
drugs throughout the United States and in this judicial district. Upon information and belief,
Alembics website, http://alembicglobal.ch/AlembicUSA.html, states that:
Alembic Pharmaceuticals Inc is the 100 % subsidiary of the
Alembic Global Holding SA. It is located in New Jersey, USA.
The basic objective of forming a wholly owned overseas
subsidiary in USA is to establish a globally recognized
organization in USA. Alembic aims as [sic] creating a strong US
presence Alembic has filed 57 ANDAs, received approval for 24
and has commercialized 15 of the approved filings. We has [sic]
also initiated Para IV and NDA filings and strengthened our
technology capability in new finished dosage forms.
12. Upon information and belief, Alembic Pharmaceuticals Ltd., Alembic Limited,
Alembic Global Holding SA and Alembic Pharmaceuticals Inc. hold themselves out as a unitary
entity for purposes of manufacturing, marketing, selling and distributing generic products. Upon
information and belief, Alembic Pharmaceuticals Ltd. and Alembic Limited are located at the
same address. Upon information and belief, Chirayu R. Amin serves as Chairman of Alembic
Pharmaceuticals Ltd., Alembic Limited and Alembic Global Holding SA.
13. Upon information and belief, Alembic Pharmaceuticals Ltd., Alembic Limited,
Alembic Global Holding SA and Alembic Pharmaceuticals Inc. work in concert with each other

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with respect to the regulatory approval, manufacturing, marketing, sale and distribution of
generic pharmaceutical products throughout the United States, including in this judicial district.
14. Upon information and belief, venue is proper in this judicial district under 28
U.S.C. 1391(b) and (c), and l400(b).
FIRST COUNT FOR PATENT INFRINGEMENT
15. The U.S. Patent and Trademark Office (PTO) issued the 615 patent on
September 13, 2011, entitled Low Hygroscopic Aripiprazole Drug Substance and Processes for
the Preparation Thereof. A copy of the 615 patent is attached as Exhibit A.
16. Otsuka is the owner of the 615 patent by virtue of assignment.
17. The 615 patent expires on December 16, 2024 (including pediatric exclusivity).
18. The 615 patent is directed to and claims, inter alia, pharmaceutical solid oral
preparations and processes for preparing pharmaceutical solid oral preparations.
19. Otsuka is the holder of New Drug Application (NDA) No. 21-436 for
aripiprazole tablets, which the FDA approved on November 15, 2002.
20. Otsuka lists the 615 patent in Approved Drug Products with Therapeutic
Equivalence Evaluations (the Orange Book) for NDA No. 21-436.
21. Otsuka markets aripiprazole tablets in the United States under the trademark
Abilify

.
22. Upon information and belief, Alembic Pharmaceuticals Ltd. submitted ANDA
No. 20-2101 to the FDA, under Section 505(j) of the Act, 21 U.S.C. 355(j), seeking approval to
manufacture, use, sale, offer to sell and import generic products containing 2, 5, 10, 15, 20 and
30 mg of aripiprazole (Alembic Pharmaceuticals Ltd.s tablet generic products) in the United
States.

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23. Otsuka received a letter from Alembic Pharmaceuticals Ltd. dated March 27,
2014 (Alembic Pharmaceuticals Ltd.s letter), purporting to include a Notice of Certification
for ANDA No. 20-2101 under 21 U.S.C. 355(j)(2)(B)(ii) and (iv) and 21 C.F.R. 314.95(c)(6)
as to the 615 patent.
24. Alembic Pharmaceuticals Ltd.s letter alleges that the active ingredient in
Alembic Pharmaceuticals Ltd.s tablet generic products for which it seeks approval is
aripiprazole.
25. Upon information and belief, Alembic Pharmaceuticals Ltd.s tablet generic
products will, if approved and marketed, infringe at least one claim of the 615 patent.
26. Upon information and belief, under 35 U.S.C. 271(e)(2)(A), Alembic
Pharmaceuticals Ltd. has infringed at least one claim of the 615 patent by submitting, or causing
to be submitted to the FDA, ANDA No. 20-2101 seeking approval to manufacture, use, sale,
offer to sell and import Alembic Pharmaceuticals Ltd.s tablet generic products before the
expiration date of the 615 patent.
27. Upon information and belief, Alembic Pharmaceuticals Ltd.s actions relating to
Alembic Pharmaceuticals Ltd.s ANDA No. 20-2101 complained of herein were done with the
cooperation, participation and assistance, and for the benefit, of Alembic Limited, Alembic
Global Holding SA and Alembic Pharmaceuticals Inc.
SECOND COUNT FOR PATENT INFRINGEMENT
28. Otsuka realleges, and incorporates in full herein, paragraphs 15-18.
29. Otsuka is the holder of NDA No. 21-729 for orally disintegrating tablets (ODT)
containing aripiprazole, which the FDA approved on June 7, 2006.
30. Otsuka lists the 615 patent in the Orange Book for NDA No. 21-729.

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31. Otsuka markets ODT containing aripiprazole in the United States under the
trademark Abilify

.
32. Upon information and belief, Alembic Pharmaceuticals Ltd. submitted ANDA
No. 20-2102 to the FDA, under Section 505(j) of the Act, 21 U.S.C. 355(j), seeking approval to
manufacture, use, sale, offer to sell and import generic products containing 10 and 15 mg of
aripiprazole (Alembic Pharmaceuticals Ltd.s ODT generic products) in the United States.
33. Alembic Pharmaceuticals Ltd.s letter purports to include a Notice of Certification
for ANDA No. 20-2102 under 21 U.S.C. 355(j)(2)(B)(ii) and (iv) and 21 C.F.R. 314.95(c)(6)
as to the 615 patent.
34. Alembic Pharmaceuticals Ltd.s letter alleges that the active ingredient in
Alembic Pharmaceuticals Ltd.s ODT generic products for which it seeks approval is
aripiprazole.
35. Upon information and belief, Alembic Pharmaceuticals Ltd.s ODT generic
products will, if approved and marketed, infringe at least one claim of the 615 patent.
36. Upon information and belief, under 35 U.S.C. 271(e)(2)(A), Alembic
Pharmaceuticals Ltd. has infringed at least one claim of the 615 patent by submitting, or causing
to be submitted to the FDA, ANDA No. 20-2102 seeking approval to manufacture, use, sale,
offer to sell and import Alembic Pharmaceuticals Ltd.s ODT generic products before the
expiration date of the 615 patent.
37. Upon information and belief, Alembic Pharmaceuticals Ltd.s actions relating to
Alembic Pharmaceuticals Ltd.s ANDA No. 20-2102 complained of herein were done with the
cooperation, participation and assistance, and for the benefit, of Alembic Limited, Alembic
Global Holding SA and Alembic Pharmaceuticals Inc.

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THIRD COUNT FOR PATENT INFRINGEMENT
38. Otsuka realleges, and incorporates in full herein, paragraphs 19, 21, 22 and 24.
39. The PTO issued the 796 patent on November 12, 2013, entitled Low
Hygroscopic Aripiprazole Drug Substance and Processes for the Preparation Thereof. A copy
of the 796 patent is attached as Exhibit B.
40. Otsuka is the owner of the 796 patent by virtue of assignment.
41. The 796 patent expires on March 25, 2023 (including pediatric exclusivity).
42. The 796 patent is directed to and claims, inter alia, aripiprazole crystals.
43. Otsuka lists the 796 patent in the Orange Book for NDA No. 21-436.
44. Alembic Pharmaceuticals Ltd.s letter purports to include a Notice of Certification
for ANDA No. 20-2101 under 21 U.S.C. 355(j)(2)(B)(ii) and (iv) and 21 C.F.R. 314.95(c)(6)
as to the 796 patent.
45. Upon information and belief, Alembic Pharmaceuticals Ltd.s tablet generic
products will, if approved and marketed, infringe at least one claim of the 796 patent.
46. Upon information and belief, under 35 U.S.C. 271(e)(2)(A), Alembic
Pharmaceuticals Ltd. has infringed at least one claim of the 796 patent by submitting, or causing
to be submitted to the FDA, ANDA No. 20-2101 seeking approval to manufacture, use, sale,
offer to sell and import Alembic Pharmaceuticals Ltd.s tablet generic products before the
expiration date of the 796 patent.
47. Upon information and belief, Alembic Pharmaceuticals Ltd.s actions relating to
Alembic Pharmaceuticals Ltd.s ANDA No. 20-2101 complained of herein were done with the
cooperation, participation and assistance, and for the benefit, of Alembic Limited, Alembic
Global Holding SA and Alembic Pharmaceuticals Inc.

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FOURTH COUNT FOR PATENT INFRINGEMENT
48. Otsuka realleges, and incorporates in full herein, paragraphs 29, 31, 32, 34 and
39-42.
49. Otsuka lists the 796 patent in the Orange Book for NDA No. 21-729.
50. Alembic Pharmaceuticals Ltd.s letter purports to include a Notice of Certification
for ANDA No. 20-2102 under 21 U.S.C. 355(j)(2)(B)(ii) and (iv) and 21 C.F.R. 314.95(c)(6)
as to the 796 patent.
51. Upon information and belief, Alembic Pharmaceuticals Ltd.s ODT generic
products will, if approved and marketed, infringe at least one claim of the 796 patent.
52. Upon information and belief, under 35 U.S.C. 271(e)(2)(A), Alembic
Pharmaceuticals Ltd. has infringed at least one claim of the 796 patent by submitting, or causing
to be submitted to the FDA, ANDA No. 20-2102 seeking approval to manufacture, use, sale,
offer to sell and import Alembic Pharmaceuticals Ltd.s ODT generic products before the
expiration date of the 796 patent.
53. Upon information and belief, Alembic Pharmaceuticals Ltd.s actions relating to
Alembic Pharmaceuticals Ltd.s ANDA No. 20-2102 complained of herein were done with the
cooperation, participation and assistance, and for the benefit, of Alembic Limited, Alembic
Global Holding SA and Alembic Pharmaceuticals Inc.
FIFTH COUNT FOR PATENT INFRINGEMENT
54. Otsuka realleges, and incorporates in full herein, paragraphs 19, 21, 22 and 24.
55. The PTO issued the 760 patent on February 4, 2014, entitled Low Hygroscopic
Aripiprazole Drug Substance and Processes for the Preparation Thereof. A copy of the 760
patent is attached as Exhibit C.

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56. Otsuka is the owner of the 760 patent by virtue of assignment.
57. The 760 patent expires on March 25, 2023 (including pediatric exclusivity).
58. The 760 patent is directed to and claims, inter alia, aripiprazole drug substance.
59. Otsuka lists the 760 patent in the Orange Book for NDA No. 21-436.
60. Alembic Pharmaceuticals Ltd.s letter purports to include a Notice of Certification
for ANDA No. 20-2101 under 21 U.S.C. 355(j)(2)(B)(ii) and (iv) and 21 C.F.R. 314.95(c)(6)
as to the 760 patent.
61. Upon information and belief, Alembic Pharmaceuticals Ltd.s tablet generic
products will, if approved and marketed, infringe at least one claim of the 760 patent.
62. Upon information and belief, under 35 U.S.C. 271(e)(2)(A), Alembic
Pharmaceuticals Ltd. has infringed at least one claim of the 760 patent by submitting, or causing
to be submitted to the FDA, ANDA No. 20-2101 seeking approval to manufacture, use, sale,
offer to sell and import Alembic Pharmaceuticals Ltd.s tablet generic products before the
expiration date of the 760 patent.
63. Upon information and belief, Alembic Pharmaceuticals Ltd.s actions relating to
Alembic Pharmaceuticals Ltd.s ANDA No. 20-2101 complained of herein were done with the
cooperation, participation and assistance, and for the benefit, of Alembic Limited, Alembic
Global Holding SA and Alembic Pharmaceuticals Inc.
SIXTH COUNT FOR PATENT INFRINGEMENT
64. Otsuka realleges, and incorporates in full herein, paragraphs 29, 31, 32, 34 and
55-58.
65. Otsuka lists the 760 patent in the Orange Book for NDA No. 21-729.

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66. Alembic Pharmaceuticals Ltd.s letter purports to include a Notice of Certification
for ANDA No. 20-2102 under 21 U.S.C. 355(j)(2)(B)(ii) and (iv) and 21 C.F.R. 314.95(c)(6)
as to the 760 patent.
67. Upon information and belief, Alembic Pharmaceuticals Ltd.s ODT generic
products will, if approved and marketed, infringe at least one claim of the 760 patent.
68. Upon information and belief, under 35 U.S.C. 271(e)(2)(A), Alembic
Pharmaceuticals Ltd. has infringed at least one claim of the 760 patent by submitting, or causing
to be submitted to the FDA, ANDA No. 20-2102 seeking approval to manufacture, use, sale,
offer to sell and import Alembic Pharmaceuticals Ltd.s ODT generic products before the
expiration date of the 760 patent.
69. Upon information and belief, Alembic Pharmaceuticals Ltd.s actions relating to
Alembic Pharmaceuticals Ltd.s ANDA No. 20-2102 complained of herein were done with the
cooperation, participation and assistance, and for the benefit, of Alembic Limited, Alembic
Global Holding SA and Alembic Pharmaceuticals Inc.
SEVENTH COUNT FOR PATENT INFRINGEMENT
70. Otsuka realleges, and incorporates in full herein, paragraphs 29, 31, 32 and 34.
71. The PTO issued the 421 patent on August 27, 2013, entitled Flashmelt Oral
Dosage Formulation. A copy of the 421 patent is attached as Exhibit D.
72. Otsuka is the owner of the 421 patent by virtue of assignment.
73. The 421 patent expires on July 24, 2021 (including pediatric exclusivity).
74. The 421 patent is directed to and claims, inter alia, flashmelt pharmaceutical
dosage forms.
75. Otsuka lists the 421 patent in the Orange Book for NDA No. 21-729.

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76. Alembic Pharmaceuticals Ltd.s letter purports to include a Notice of Certification
for ANDA No. 20-2102 under 21 U.S.C. 355(j)(2)(B)(ii) and (iv) and 21 C.F.R. 314.95(c)(6)
as to the 421 patent.
77. Upon information and belief, Alembic Pharmaceuticals Ltd.s ODT generic
products will, if approved and marketed, infringe at least one claim of the 421 patent.
78. Upon information and belief, under 35 U.S.C. 271(e)(2)(A), Alembic
Pharmaceuticals Ltd. has infringed at least one claim of the 421 patent by submitting, or causing
to be submitted to the FDA, ANDA No. 20-2102 seeking approval to manufacture, use, sale,
offer to sell and import Alembic Pharmaceuticals Ltd.s ODT generic products before the
expiration date of the 421 patent.
79. Upon information and belief, Alembic Pharmaceuticals Ltd.s actions relating to
Alembic Pharmaceuticals Ltd.s ANDA No. 20-2102 complained of herein were done with the
cooperation, participation and assistance, and for the benefit, of Alembic Limited, Alembic
Global Holding SA and Alembic Pharmaceuticals Inc.
WHEREFORE, Plaintiff Otsuka respectfully requests that the Court enter judgment in
its favor and against Defendants Alembic Pharmaceuticals Ltd., Alembic Limited, Alembic
Global Holding SA and Alembic Pharmaceuticals Inc. on the patent infringement claims set forth
above and respectfully requests that this Court:
1) enter judgment that, under 35 U.S.C. 271(e)(2)(A), Alembic has infringed at least
one claim of the 615 patent through Alembic Pharmaceuticals Ltd.s submission of
ANDA No. 20-2101 to the FDA to obtain approval to manufacture, use, sale, offer
to sell and import Alembic Pharmaceuticals Ltd.s tablet generic products in the
United States before the expiration of the 615 patent;

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2) order that the effective date of any approval by the FDA of Alembic
Pharmaceuticals Ltd.s tablet generic products be a date that is not earlier than the
expiration of the 615 patent, or such later date as the Court may determine;
3) enjoin Alembic from the manufacture, use, sale, offer to sell and import of Alembic
Pharmaceuticals Ltd.s tablet generic products until the expiration of the 615
patent, or such later date as the Court may determine;
4) enjoin Alembic and all persons acting in concert with Alembic, from seeking,
obtaining or maintaining approval of Alembic Pharmaceuticals Ltd.s ANDA No.
20-2101 until the expiration of the 615 patent;
5) enter judgment that, under 35 U.S.C. 271(e)(2)(A), Alembic has infringed at least
one claim of the 615 patent through Alembic Pharmaceuticals Ltd.s submission of
ANDA No. 20-2102 to the FDA to obtain approval to manufacture, use, sale, offer
to sell and import Alembic Pharmaceuticals Ltd.s ODT generic products in the
United States before the expiration of the 615 patent;
6) order that the effective date of any approval by the FDA of Alembic
Pharmaceuticals Ltd.s ODT generic products be a date that is not earlier than the
expiration of the 615 patent, or such later date as the Court may determine;
7) enjoin Alembic from the manufacture, use, sale, offer to sell and import of Alembic
Pharmaceuticals Ltd.s ODT generic products until the expiration of the 615
patent, or such later date as the Court may determine;
8) enjoin Alembic and all persons acting in concert with Alembic, from seeking,
obtaining or maintaining approval of Alembic Pharmaceuticals Ltd.s ANDA No.
20-2102 until the expiration of the 615 patent;

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9) enter judgment that, under 35 U.S.C. 271(e)(2)(A), Alembic has infringed at least
one claim of the 796 patent through Alembic Pharmaceuticals Ltd.s submission of
ANDA No. 20-2101 to the FDA to obtain approval to manufacture, use, sale, offer
to sell and import Alembic Pharmaceuticals Ltd.s generic products in the United
States before the expiration of the 796 patent;
10) order that the effective date of any approval by the FDA of Alembic
Pharmaceuticals Ltd.s tablet generic products be a date that is not earlier than the
expiration of the 796 patent, or such later date as the Court may determine;
11) enjoin Alembic from the manufacture, use, sale, offer to sell and import of Alembic
Pharmaceuticals Ltd.s tablet generic products until the expiration of the 796
patent, or such later date as the Court may determine;
12) enjoin Alembic and all persons acting in concert with Alembic, from seeking,
obtaining or maintaining approval of Alembic Pharmaceuticals Ltd.s ANDA No.
20-2101 until the expiration of the 796 patent;
13) enter judgment that, under 35 U.S.C. 271(e)(2)(A), Alembic has infringed at least
one claim of the 796 patent through Alembic Pharmaceuticals Ltd.s submission of
ANDA No. 20-2102 to the FDA to obtain approval to manufacture, use, sale, offer
to sell and import Alembic Pharmaceuticals Ltd.s ODT generic products in the
United States before the expiration of the 796 patent;
14) order that the effective date of any approval by the FDA of Alembic
Pharmaceuticals Ltd.s ODT generic products be a date that is not earlier than the
expiration of the 796 patent, or such later date as the Court may determine;

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15) enjoin Alembic from the manufacture, use, sale, offer to sell and import of Alembic
Pharmaceuticals Ltd.s ODT generic products until the expiration of the 796
patent, or such later date as the Court may determine;
16) enjoin Alembic and all persons acting in concert with Alembic, from seeking,
obtaining or maintaining approval of Alembic Pharmaceuticals Ltd.s ANDA No.
20-2102 until the expiration of the 796 patent;
17) enter judgment that, under 35 U.S.C. 271(e)(2)(A), Alembic has infringed at least
one claim of the 760 patent through Alembic Pharmaceuticals Ltd.s submission of
ANDA No. 20-2101 to the FDA to obtain approval to manufacture, use, sale, offer
to sell and import Alembic Pharmaceuticals Ltd.s tablet generic products in the
United States before the expiration of the 760 patent;
18) order that the effective date of any approval by the FDA of Alembic
Pharmaceuticals Ltd.s tablet generic products be a date that is not earlier than the
expiration of the 760 patent, or such later date as the Court may determine;
19) enjoin Alembic from the manufacture, use, sale, offer to sell and import of Alembic
Pharmaceuticals Ltd.s tablet generic products until the expiration of the 760
patent, or such later date as the Court may determine;
20) enjoin Alembic and all persons acting in concert with Alembic, from seeking,
obtaining or maintaining approval of Alembic Pharmaceuticals Ltd.s ANDA No.
20-2101 until the expiration of the 760 patent;
21) enter judgment that, under 35 U.S.C. 271(e)(2)(A), Alembic has infringed at least
one claim of the 760 patent through Alembic Pharmaceuticals Ltd.s submission of
ANDA No. 20-2102 to the FDA to obtain approval to manufacture, use, sale, offer

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to sell and import Alembic Pharmaceuticals Ltd.s ODT generic products in the
United States before the expiration of the 760 patent;
22) order that the effective date of any approval by the FDA of Alembic
Pharmaceuticals Ltd.s ODT generic products be a date that is not earlier than the
expiration of the 760 patent, or such later date as the Court may determine;
23) enjoin Alembic from the manufacture, use, sale, offer to sell and import of Alembic
Pharmaceuticals Ltd.s ODT generic products until the expiration of the 760
patent, or such later date as the Court may determine;
24) enjoin Alembic and all persons acting in concert with Alembic, from seeking,
obtaining or maintaining approval of Alembic Pharmaceuticals Ltd.s ANDA No.
20-2102 until the expiration of the 760 patent;
25) enter judgment that, under 35 U.S.C. 271(e)(2)(A), Alembic has infringed at least
one claim of the 421 patent through Alembic Pharmaceuticals Ltd.s submission of
ANDA No. 20-2102 to the FDA to obtain approval to manufacture, use, sale, offer
to sell and import Alembic Pharmaceuticals Ltd.s ODT generic products in the
United States before the expiration of the 421 patent;
26) order that the effective date of any approval by the FDA of Alembic
Pharmaceuticals Ltd.s ODT generic products be a date that is not earlier than the
expiration of the 421 patent, or such later date as the Court may determine;
27) enjoin Alembic from the manufacture, use, sale, offer to sell and import of Alembic
Pharmaceuticals Ltd.s ODT generic products until the expiration of the 421
patent, or such later date as the Court may determine;

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28) enjoin Alembic and all persons acting in concert with Alembic, from seeking,
obtaining or maintaining approval of Alembic Pharmaceuticals Ltd.s ANDA No.
20-2102 until the expiration of the 421 patent;
29) declare this to be an exceptional case under 35 U.S.C. 285 and 271(e)(4) and
award Otsuka costs, expenses and disbursements in this action, including
reasonable attorney fees; and
30) award Otsuka such further and additional relief as this Court deems just and proper.

Respectfully submitted,

s/ John F. Brenner
John F. Brenner
Melissa A. Chuderewicz
brennerj@pepperlaw.com
chuderem@pepperlaw.com
PEPPER HAMILTON LLP
Suite 400
301 Carnegie Center
Princeton, New Jersey 08543
(609) 452-0808
Attorneys for Plaintiff
Otsuka Pharmaceutical Co., Ltd.

Dated: May 9, 2014

Of Counsel:

James B. Monroe
Paul W. Browning
Denise Main
FINNEGAN, HENDERSON,
FARABOW, GARRETT & DUNNER, LLP
901 New York Avenue, N.W.
Washington, DC 20001-4413
(202) 408-4000